Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

March 30, 2021 updated by: Sun Gun Chung, Seoul National University Hospital
The investigators developed a real-time 2-axis mirror robot system as a simple add-on module for conventional mirror therapy using a closed feedback mechanism, which allows for real-time movement of the hemiplegic arm. The investigators conduct a case study for stroke patients with a two-dimensional mirror robot for 30 min per day for two weeks (10 sessions). For the conventional mirror therapy group, the investigators prepared the tasks for fine motor training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators conduct a case study for stroke patients with a two-dimensional mirror robot for 30 min per day for two weeks (10 sessions). For the conventional mirror therapy group, the investigators prepared the tasks for fine motor training. These tasks included more complicated tasks so that the participants would be interested in the tasks without the robot system.

Before and after 10 sessions of the therapy, the investigators conduct functional evaluations: the Fugl-Meyer assessment scale of the upper extremity (FMA-UE), the modified Ashworth scale, the modified Barthel index of upper extremity (MBI-UE: personal hygiene, bathing, feeding, and dressing), and the Jebsen hand function test, hand power measurement, and hemispatial neglect test (line bisection test and Albert's test) with the same occupational therapist. The motor evoked potential was measured for the patients without the history of brain surgery or seizure.

The investigators selected a thumb finding test (TFT) among various tools for assessing proprioception, because TFT is widely used and reliable. The TFT can be assessed, after confirming normal proprioception in the unaffected arm, by the patient touching the nose with their eyes closed while the examiner lifts the affected arm to eye level. The patient is then asked to grasp the thumb of the affected hand with the unaffected hand, and this is repeated. The examiner then places a hand over the patient's eyes and raises the patient's affected hand to well above the patient's head. The patient is then asked to grasp the thumb as before.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 18 years old
  • Supratentorial stroke diagnosed between 4 months and 6 years ago
  • Upper-limb hemiplegia with Medical Research Council grade 2 or less.

Exclusion Criteria:

  • Severe spasticity with modified Ashworth scale of grade 3 or more;
  • Mini-mental state examination score less than 12
  • Global or sensory aphasia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic mirror therapy
For 30 min per day for two weeks (10 sessions)
Device: Robotic mirror therapy
2-dimensional
Active Comparator: Conventional mirror therapy
For 30 min per day for two weeks (10 sessions)
Device: Conventional mirror therapy
2- and 3-dimensional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl-Meyer assessment scale
Time Frame: Change from baseline data at 2 weeks
Change from baseline data at 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Thumb finding test
Time Frame: Before treatment, after 2 weeks, after 2 months
Before treatment, after 2 weeks, after 2 months
Modified Ashworth scale
Time Frame: Before treatment, after 2 weeks, after 2 months
Before treatment, after 2 weeks, after 2 months
Modified Barthel index
Time Frame: Before treatment, after 2 weeks, after 2 months
Before treatment, after 2 weeks, after 2 months
Hand power(lb) assessed by dynamometer
Time Frame: Before treatment, after 2 weeks, after 2 months
Before treatment, after 2 weeks, after 2 months
Jebsen hand function test
Time Frame: Before treatment, after 2 weeks, after 2 months
Before treatment, after 2 weeks, after 2 months
Hemispatial neglect test
Time Frame: Before treatment, after 2 weeks, after 2 months
Before treatment, after 2 weeks, after 2 months
Functional brain MRI
Time Frame: Before treatment, after 2 weeks
Before treatment, after 2 weeks
Fugl-Meyer assessment scale
Time Frame: after 2 months
after 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 21, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

April 2, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-1209-051-425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Robotic mirror therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe